Cleared Special

Onflex? Mesh

K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc. · General & Plastic Surgery

Jul 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K251955 is an FDA 510(k) clearance for the Onflex? Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Davol Inc., Subsidiary of C. R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on July 24, 2025, 29 days after receiving the submission on June 25, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K251955 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2025
Decision Date	July 24, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF